CN111514237B - 一种治疗病毒性心肌炎的中药组合物及其制备方法 - Google Patents
一种治疗病毒性心肌炎的中药组合物及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种治疗病毒性心肌炎的中药组合物及其制备方法,属于中药技术领域。该中药组合物由以下重量份的原料制成:党参6‑10份、黄芪9‑15份、太子参4‑8份、制黄精6‑10份、玉竹6‑10份、茯苓6‑10份、甘松4‑8份、丹参6‑10份、连翘6‑10份、白薇6‑10份、炙甘草6‑10份、五味子6‑10份、白芍6‑10份、桂枝6‑10份、麦冬6‑10份、桔梗3‑6份、川芎6‑10份。制备方法为:将各原料混合,加水作提取溶剂,煎煮提取2次,过滤,得到滤液;滤液减压浓缩至浸膏,真空干燥后,即得。本发明中药组合物具有补益少阴心经气血阴阳,益气固本、育阴通阳、调和营卫、解毒利咽、养心定悸等功效,在数十年治疗病毒性心肌炎的应用中,取得了显著临床疗效。
Description
技术领域
本发明属于中药技术领域,尤其涉及一种治疗病毒性心肌炎的中药组合物及其制备方法。
背景技术
病毒性心肌炎是由病毒感染引起的心肌局限性或弥漫性炎症为主要特征的疾病,好发于青壮年,是心血管方面疾病的常见病种。罹患本病后,可造成自身免疫功能下降,易发生呼吸道疾病,加重病毒性心肌炎病情。急性或慢性的炎症过程影响心脏,造成炎症细胞浸润、间质水肿、局灶心肌坏死和纤维化。临床症见胸痛、劳力性呼吸困难、乏力、晕厥、心悸、心律失常、心力衰竭等。
目前,西医多以抗病毒、营养心肌、抗氧化等治疗为主,整体效果较差,药量较大,不易吸收。中医方面通过辨证、分型后予中药治疗,实验研究和临床观察证明,中药在治疗病毒性心肌炎方面有一定效果。例如,针对“气阴两虚型”病毒性心肌炎,采用“荣心丸”治疗,其成份为玉竹、炙甘草、五味子、丹参、降香、山楂、大青叶、苦参,功效为益气养阴,活血解毒,用于气阴两虚或气阴两虚兼心脉瘀阻所致的胸闷、心悸、气短、乏力、头晕、多汗、心前区不适或疼痛;针对“气血两虚型”病毒性心肌炎,采用“茵陈四物汤”加减治疗,其成份为红参9g、熟地黄12g、酒当归9g、川芎20g、赤芍15g、茵陈30g、焦三仙24g、煅牡蛎20g、黄连12g、炒苍术15g、麸炒白术15g、甘松12g、龙眼肉30g、炙甘草6g。然而,心脏的正常功能由气血阴阳共同维护,少阴心经属君火,气阴两虚日久,阴损及阳,逐渐伤及心阳,“荣心丸”和“茵陈四物汤”则没有显著疗效。同时,“荣心丸”成份中的苦参极苦且为大蜜丸剂型,服用重量大,口感较差;“茵陈四物汤”中的茵陈、黄连清利湿热,对于湿热偏重的患者较为适宜,湿热一旦清除,用药则有寒凉伤阴之弊,故不适合长期服用,而本病迁延日久且多见气阴两虚证,显然“茵陈四物汤”不宜用于此证型,存在适宜证型较为局限的问题,且成份中包含黄连、茵陈等味苦味重的药材,对于儿童患者有用药困难的问题。
因此,针对西医治疗效果差,不易吸收;中医治疗药量大、口感较差、用药困难及适宜证型较为局限的问题,有必要开发一种临床疗效显著,口感较好且适宜证型宽泛的治疗病毒性心肌炎的中药组合物。
发明内容
有鉴于此,本发明提供一种治疗病毒性心肌炎的中药组合物及其制备方法,该中药组合物临床治疗病毒性心肌炎效果显著,口感较好,利于儿童患者服用。
为了实现上述目的,本发明采用以下技术方案:
本发明提供了一种治疗病毒性心肌炎的中药组合物,以重量份计,由以下原料制成:党参6-10份、黄芪9-15份、太子参4-8份、制黄精6-10份、玉竹6-10份、茯苓6-10份、甘松4-8份、丹参6-10份、连翘6-10份、白薇6-10份、炙甘草6-10份、五味子6-10份、白芍6-10份、桂枝6-10份、麦冬6-10份、桔梗3-6份、川芎6-10份。
优选地,以重量份计,所述中药组合物由以下原料制成:
党参8-10份、黄芪12-15份、太子参5-8份、制黄精8-10份、玉竹8-10份、茯苓8-10份、甘松5-8份、丹参8-10份、连翘8-10份、白薇8-10份、炙甘草8-10份、五味子8-10份、白芍8-10份、桂枝8-10份、麦冬8-10份、桔梗4-6份、川芎8-10份。
更优选地,以重量份计,所述中药组合物由以下原料制成:
党参9份、黄芪13份、太子参6份、制黄精9份、玉竹9份、茯苓9份、甘松6份、丹参9份、连翘9份、白薇9份、炙甘草9份、五味子9份、白芍9份、桂枝9份、麦冬9份、桔梗5份、川芎9份。
本发明还提供了一种治疗病毒性心肌炎的中药组合物的制备方法,包括:
将所述中药组合物的各原料混合,加水作提取溶剂,煎煮提取2次,过滤后,得到滤液;
将所述滤液减压浓缩至稠膏状浸膏,真空干燥后,即得。
优选地,所述提取溶剂的用量为药物总重量的8-10倍。
优选地,所述煎煮提取第一次在100-150℃的温度下进行,时间为30分钟。
优选地,所述煎煮提取第二次在100-120℃的温度下进行,时间为20分钟。
本发明还提供了所述中药组合物在制备治疗病毒性心肌炎的药物中的应用。
本发明还提供了一种治疗病毒性心肌炎的中药制剂,由所述治疗病毒性心肌炎的中药组合物及药学上可接受的辅料制成。
与现有技术相比,本发明的有益效果在于:
本发明中药组合物以补益少阴心经为主,具有调节少阴心经气血阴阳,益气固本、育阴通阳、调和营卫、解毒利咽、养心定悸的功效,标本兼职,凉而不寒,不伤正气,可适宜于多种证型病毒性心肌炎的治疗,经数十年临床应用具有显著疗效;该中药组合物的苦味较轻,口感较好,利于儿科患者服用,解决了现有治疗本病的中药口感较差、药量大、用药困难及适宜证型较为局限的问题。
具体实施方式
为了进一步理解本发明,下面结合实施例对本发明优选实施方案进行描述,但是应当理解,这些描述只是为进一步说明本发明的特征和优点,而不是对本发明权利要求的限制。
本发明提供了一种治疗病毒性心肌炎的中药组合物,以重量份计,由如下原料药制成:党参6-10份、黄芪9-15份、太子参4-8份、制黄精6-10份、玉竹6-10份、茯苓6-10份、甘松4-8份、丹参6-10份、连翘6-10份、白薇6-10份、炙甘草6-10份、五味子6-10份、白芍6-10份、桂枝6-10份、麦冬6-10份、桔梗3-6份、川芎6-10份。
其中,本发明对所有原料的来源并没有特殊的限制,为市售即可。
所述党参的重量含量优选为8-10份,更优选用量为9份。党参,健脾益肺,养血生津,并抗缺氧及增强免疫机能。
所述黄芪的重量含量优选为12-15份,更优选用量为13份。黄芪,抑菌,补气升阳,固表止汗,利水消肿,生津养血,行滞通痹,托毒排脓,敛疮生肌,并加强正常心脏收缩,扩张管状血管和肾脏血管。
所述太子参的重量含量优选为5-8份,更优选用量为6份。太子参,益气健脾,生津润肺。
所述制黄精的重量含量优选为8-10份,更优选用量为9份。制黄精,补气养阴,健脾、润肺、益肾,并有抗菌和降压作用。
所述玉竹的重量含量优选为8-10份,更优选用量为9份。玉竹,养阴润燥,生津止渴,并扩张血管和增强机体免疫功能。
所述茯苓的重量含量优选为8-10份,更优选用量为9份。茯苓,利水渗湿,健脾,宁心,利尿,抗菌。
所述甘松的重量含量优选为5-8份,更优选用量为6份。甘松,理气止痛,开郁醒脾,并抗心律不整及抗菌、驱风及解痉。
所述丹参的重量含量优选为8-10份,更优选用量为9份。丹参,活血祛瘀,通经止痛,清心除烦,凉血消痈,并保护心肌缺血缺氧及抗菌、消炎。
所述连翘的重量含量优选为8-10份,更优选用量为9份。连翘,清热解毒,消肿散结,疏散风热及抗菌。
所述白薇的重量含量优选为8-10份,更优选用量为9份。白薇,清热凉血,利尿通淋,解毒疗疮。
所述炙甘草的重量含量优选为8-10份,更优选用量为9份。炙甘草,补脾和胃,益气复脉,调和诸药。
所述五味子的重量含量优选为8-10份,更优选用量为9份。五味子,收敛固涩,益气生津,补肾宁心。
所述白芍的重量含量优选为8-10份,更优选用量为9份。白芍,养血调经,敛阴止汗,柔肝止痛,平抑肝阳,并扩张血管,抗菌消炎。
所述桂枝的重量含量优选为8-10份,更优选用量为9份。桂枝,发汗解肌,温通经脉,助阳化气,平冲降气,抗菌、抗病毒。
所述麦冬的重量含量优选为8-10份,更优选用量为9份。麦冬,养阴生津,润肺清心。
所述桔梗的重量含量优选为4-6份,更优选用量为5份。桔梗,宣肺,利咽,祛痰,排脓。
所述川芎的重量含量优选为8-10份,更优选用量为9份。川芎,活血行气,祛风止痛,对抗急性心肌缺血缺氧并抗菌。
在本发明提供的一些实施例中,中药组合物由以下重量份的药材制成:
党参9份、黄芪13份、太子参6份、制黄精9份、玉竹9份、茯苓9份、甘松6份、丹参9份、连翘9份、白薇9份、炙甘草9份、五味子9份、白芍9份、桂枝9份、麦冬9份、桔梗5份、川芎9份。
在本发明提供的一些实施例中,中药组合物由以下重量份的药材制成:
党参8份、黄芪12份、太子参5份、制黄精8份、玉竹8份、茯苓8份、甘松5份、丹参8份、连翘8份、白薇8份、炙甘草8份、五味子8份、白芍8份、桂枝8份、麦冬8份、桔梗4份、川芎8份。
在本发明提供的一些实施例中,中药组合物由以下重量份的药材制成:
党参6份、黄芪9份、太子参4份、制黄精6份、玉竹6份、茯苓6份、甘松4份、丹参6份、连翘6份、白薇6份、炙甘草6份、五味子6份、白芍6份、桂枝6份、麦冬6份、桔梗3份、川芎6份。
在本发明提供的另外一些实施例中,中药组合物由以下重量份的药材制成:
党参10份、黄芪15份、太子参8份、制黄精10份、玉竹10份、茯苓10份、甘松8份、丹参10份、连翘10份、白薇10份、炙甘草10份、五味子10份、白芍10份、桂枝10份、麦冬10份、桔梗6份、川芎10份。
药理解析:本发明以调治少阴心经为主,而《黄帝内经·素问》“心者,君主之官也,神明出焉。”心经气血阴阳正常,才能维持心脏的功能正常运行,故治疗当补益心经气血阴阳。方中以党参、黄芪、太子参补心气;制黄精、玉竹、麦冬、五味子滋心阴;桂枝、炙甘草温心阳;丹参、白芍、川芎养心血,共为调治少阴心经主药,同时桂枝、白芍、炙甘草兼有调和营卫功效。病毒性心肌炎迁延不愈,多见气阴两虚证,故方中补心气,补心阴多用药味。桔梗利咽解毒防治咽部感染;连翘、白薇清热解毒,逐邪外出,防治外感,三味共为臣。茯苓安神养心,淡渗利水,消除心肌炎症水肿为佐;甘松芳香理气,条畅体内气机,使补而不滞,气行血行,配茯苓有良好的养心定悸功效,为使。全方以调治少阴心经为主,防治外感为辅,扶正祛邪,凉而不寒,不伤正气。上述诸药组合,具有补益心脏气血阴阳,益气固本、养心通阳、补益心气、育阴定悸、调和营卫等功效,能够改善心肌代谢,促进心肌修复,改善心肌微循环
本发明以患者心气虚、心阴虚、心血虚、心阳虚为本,反复呼吸道感染、频繁心律失常为标,故本方通过补益少阴心经气血阴阳扶正固本,以治本;以清热利咽解毒的连翘、白薇、桔梗祛除外邪,达到逐邪外出的祛邪效果,茯苓、甘松养心定悸治疗心律失常,以治标,本标兼治,用于治疗病毒性心肌炎临床疗效显著。
本发明中药组合物的苦味较轻,口感较好,更利于儿科患者服用。
本发明还提供了一种治疗病毒性心肌炎的中药组合物的制备方法,包括:
将所述中药组合物的各原料混合,加水作提取溶剂,煎煮提取2次,过滤,得到滤液;
将所述滤液减压浓缩至浸膏,真空干燥后,即得。
优选地,所述提取溶剂的用量为药物总重量的8-10倍。
优选地,所述煎煮提取第一次在100-150℃的温度下进行,时间为30分钟。
优选地,所述煎煮提取第二次在100-120℃的温度下进行,时间为20分钟。
本发明还提供了所述中药组合物在制备治疗病毒性心肌炎的药物中的应用。
本发明还提供了一种治疗病毒性心肌炎的中药制剂,由所述中药组合物及药学上可接受的辅料制成。
为了进一步说明本发明,以下结合实施例对本发明进行详细描述。
实施例1-所述治疗病毒性心肌炎的中药组合物的制备
将9克党参、13克黄芪、6克太子参、9克制黄精、9克玉竹、9克茯苓、6克甘松、9克丹参、9克连翘、9克白薇、9克炙甘草、9克五味子、9克白芍、9克桂枝、9克麦冬、5克桔梗和9克川芎混合,加1400克水作提取溶剂,在100-150℃的温度下煎煮30分钟,再在100-120℃的温度下,煎煮20分钟,过滤后,得到滤液;将所述滤液减压浓缩至相对密度为1.20(室温)的浸膏,真空干燥后,即得。
实施例2-所述治疗病毒性心肌炎的中药组合物的制备
将8克党参、12克黄芪、5克太子参、8克制黄精、8克玉竹、8克茯苓、5克甘松、8克丹参、8克连翘、8克白薇、8克炙甘草、8克五味子、8克白芍、8克桂枝、8克麦冬、4克桔梗和8克川芎混合,加1200克水作提取溶剂,在100-150℃的温度下煎煮30分钟,再在100-120℃的温度下,煎煮20分钟,过滤后,得到滤液;将所述滤液减压浓缩至相对密度为1.20(室温)的浸膏,真空干燥后,即得。
实施例3-所述治疗病毒性心肌炎的中药组合物的制备
将6克党参、9克黄芪、4克太子参、6克制黄精、6克玉竹、6克茯苓、4克甘松、6克丹参、6克连翘、6克白薇、6克炙甘草、6克五味子、6克白芍、6克桂枝、6克麦冬、3克桔梗和6克川芎混合,加1000克水作提取溶剂,在100-150℃的温度下煎煮30分钟,再在100-120℃的温度下,煎煮20分钟,过滤后,得到滤液;将所述滤液减压浓缩至相对密度为1.20(室温)的浸膏,真空干燥后,即得。
实施例4-所述治疗病毒性心肌炎的中药组合物的制备
将10克党参、15克黄芪、8克太子参、10克制黄精、10克玉竹、10克茯苓、8克甘松、10克丹参、10克连翘、10克白薇、10克炙甘草、10克五味子、10克白芍、10克桂枝、10克麦冬、6克桔梗和10克川芎混合,加1600克水作提取溶剂,在100-150℃的温度下煎煮30分钟,再在100-120℃的温度下,煎煮20分钟,过滤后,得到滤液;将所述滤液减压浓缩至相对密度为1.20(室温)的浸膏,真空干燥后,即得。
实施例5-所述治疗病毒性心肌炎的中药组合物的临床制剂
本发明实施例1-4所述治疗病毒性心肌炎的中药组合物,按照常规的药品生产工艺,加入适宜的矫味剂或甜味剂,制成颗粒剂;加入适宜的辅料,制成片剂、散剂或胶囊剂等口服固体制剂。
实施例6-所述治疗病毒性心肌炎的中药组合物临床疗效观察
1.一般病例资料:
所有病例均来自我院2015年1月至2017年12月门诊患者,取得患者及家属同意后,将76例临床确诊病毒性心肌炎患者随机均分为治疗组及对照组,治疗组因故退出2例,对照组因故退出3例,实际入组病例,治疗组36例,对照组35例。
2.诊断标准:根据“成人急性病毒性心肌炎诊断参考标准”及“小儿病毒性心肌炎诊断标准”确诊。
3.治疗方法:
实验组服用实施例1制备的中药组合物,每次1.6克,每日三次;对照组服用市售的辅酶Q10及维生素C。治疗期间停止其他中西药治疗。
4.疗效判断标准:根据《中医病证诊断疗效标准》
治愈:临床症状、体征消失,血清酶学(CK、LDH)检查完全恢复正常,心电图检查T波、sT段和异常Q波基本恢复正常;
有效:临床症状、体征减轻,血清学检查基本恢复正常,心电图检查T波和ST段较治疗前明显好转或基本恢复正常;
无效:临床症状、体征、血清酶学检查及心电图检查均无改善。
5.治疗结果:
治疗4周后,观察临床疗效见表1。
总有效率治疗组86.84%,对照组62.16%,差异有统计学意义(P<0.05),治疗组优于对照组。
表1治疗4周后2组临床疗效比较例(%)
从表1可以看出,本发明所述中药组合物在临床治疗病毒性心肌炎中取得了较好的疗效,在38例病毒性心肌炎患者中,服用本发明所述中药组合物4周后,显效9例,有效24例,无效5例,总有效率为86.84%,无效率占13.16%。
治疗8周后,观察临床疗效见表2。
总有效率治疗组91.67%,对照组72.22%,差异有统计学意义(P<0.05),治疗组优于对照组。
表2治疗8周后2组临床疗效比较例(%)
从表2可以看出,本发明所述中药组合物在临床治疗病毒性心肌炎中取得了较好的疗效,在36例病毒性心肌炎患者中,服用本发明所述中药组合物8周后,显效13例,有效20例,无效3例,总有效率为91.67%,无效率占8.33%。
治疗12周后,观察临床疗效见表3。
总有效率治疗组97.22%,对照组74.29%,差异有统计学意义(P<0.05),治疗组优于对照组。
表3治疗12周后2组临床疗效比较例(%)
从表3可以看出,本发明所述中药组合物在临床治疗病毒性心肌炎中取得了较好的疗效,在36例病毒性心肌炎患者中,服用本发明所述中药组合物12周后,显效16例,有效19例,无效1例,总有效率为97.22%,无效率占2.78%。
通过上述可知,在治疗4周、8周、12周后,治疗组总有效率明显优于对照组,差异有统计学意义(P<0.05)。
5.临床病例:
病例一:张X,8岁,保定市安新县人,由北京市儿童院诊断为:病毒性心肌炎,频发室性期前收缩。治疗2年,症状反复发作。2006年3月来诊时,心肌酶:CK191U/L AST128U/LLDH213U/L。24小时动态心电图:窦性心律频发室性期前收缩,室上性、室性期前收缩总数大于6000次/24小时。服用本方1个月,室性期前收缩小于700次/24小时,心肌酶改善。服用本方3个月后复查,24小时动态心电图示:室上性、室性期前收缩总数小于50次/24小时,心肌酶正常。
病例二:王XX,5岁,保定市人,由保定市三甲医院诊断为:病毒性心肌炎,频繁室上性、室性期前收缩,治疗1年,胸闷心悸,反复感冒,频繁请假,从幼儿园退学。2011年5月来诊时,心肌酶:CK146U/L AST105U/L LDH122U/L CK-MB64U/L。24小时动态心电图:窦性心律频发室上性、室性期前收缩,室上性、室性期前收缩总数3000次/24小时左右。服用本方1个月,室上性、室性期前收缩减少,心肌酶正常。服用本方2个月后复查,24小时动态心电图示:室上性、室性期前收缩总数小于30次/24小时。心肌酶正常。
以上所述仅为本发明较佳的具体实施方式,但本发明的保护范围并不局限于此,任何熟悉本技术的技术人员在本发明批露的技术范围内,根据本发明的技术方案及其发明构思加以等同替换或改变,都涵盖在本发明的保护范围内。
Claims (9)
1.一种治疗病毒性心肌炎的中药组合物,其特征在于,由以下重量份的原料制成:党参6-10份、黄芪9-15份、太子参4-8份、制黄精6-10份、玉竹6-10份、茯苓6-10份、甘松4-8份、丹参6-10份、连翘6-10份、白薇6-10份、炙甘草6-10份、五味子6-10份、白芍6-10份、桂枝6-10份、麦冬6-10份、桔梗3-6份、川芎6-10份。
2.根据权利要求1所述的中药组合物,其特征在于,由以下重量份的原料制成:党参8-10份、黄芪12-15份、太子参5-8份、制黄精8-10份、玉竹8-10份、茯苓8-10份、甘松5-8份、丹参8-10份、连翘8-10份、白薇8-10份、炙甘草8-10份、五味子8-10份、白芍8-10份、桂枝8-10份、麦冬8-10份、桔梗4-6份、川芎8-10份。
3.根据权利要求2所述的中药组合物,其特征在于,由以下重量份的原料制成:党参9份、黄芪13份、太子参6份、制黄精9份、玉竹9份、茯苓9份、甘松6份、丹参9份、连翘9份、白薇9份、炙甘草9份、五味子9份、白芍9份、桂枝9份、麦冬9份、桔梗5份、川芎9份。
4.一种治疗病毒性心肌炎的中药组合物的制备方法,其特征在于,包括:
将所述中药组合物的各原料混合,加水作提取溶剂,煎煮提取2次,过滤,得到滤液;
将所述滤液减压浓缩至浸膏,真空干燥后,即得。
5.根据权利要求4所述的制备方法,其特征在于,所述提取溶剂的用量为所述药材总重量的8-10倍。
6.根据权利要求4所述的制备方法,其特征在于,所述煎煮提取第一次在100-150℃的温度下进行,时间为30分钟。
7.根据权利要求4所述的制备方法,其特征在于,所述煎煮提取第二次在100-120℃的温度下进行,时间为20分钟。
8.根据权利要求1-3任一所述的中药组合物或权利要求4-7任一所制备的中药组合物在制备治疗病毒性心肌炎的药物中的应用。
9.一种治疗病毒性心肌炎的中药制剂,其特征在于,由权利要求1-3任一所述的中药组合物或权利要求4-7任一所制备的中药组合物及药学上可接受的辅料制成。
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